FDA.reportPublic FDA data

PI-CARDIA LTD

Matched from indexed company URL: Pi-Cardia Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30304715253030471525PI-CARDIA LTD1N2026-01-01David Fikes 5 Rehovot Central IL 7632805
30333075373033307537Pi-Cardia Inc1Y2026-01-011 Broadway Ct Cambridge MA US 02138

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07290020101242ShortCut - Percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures.888) 705-5366customerservice@pi-cardia.net

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3324691506217474DEN240017ShortCutSCZ2024-09-27
3333151506217474DEN240017ShortCutSCZ2024-09-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SCZ22024-09-27

GUDID#